BeyondSpring Inc. [NASDAQ: BYSI] disclosed that it has submitted a New Drug Application to the US FDA and China National Medical Products Administration (NMPA). The firm has submitted an application for the use of plinabulin along with granulocyte colony-stimulating factor (G-CSF) for the inhibition of chemotherapy-induced neutropenia (CIN).
Plinabulin along with G-CSF has been granted advanced treatment labels from the U.S. FDA and the China NMPA. The patients living with CIN have been waiting for the new cure, but it always remains an unmet medical need. Therapy or the avoidance of CIN with G-CSF has been the standard of care since Neupogen was ratified in 1991.
Basis of NDA Submission
The submission of NDA by BeyondSpring is centered on the PROTECTIVE-2 Phase III registration study by BYSI. The trial has demonstrated that the use of plinabulin along with pegfilgrastim is proven to be more useful in providing prevention against CIN in contrast to the use of pegfilgrastim alone for the prevention. The trial has fulfilled the primary endpoint and has shown the benefit against the disease.
About PROTECTIVE-2 Phase III Registration Study
The PROTECTIVE-2 Phase III registration study was carried out to find out the effectiveness of the cure with plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) against a single dose of pegfilgrastim (6 mg, Day 2 dose) in sufferers with breast cancer.
Result of PROTECTIVE-2 Phase III Study
The PROTECTIVE-2 Phase III trial has shown that the combination is well endured in the sufferers who are living with CIN. The study demonstrated that the around 20% decline of grade 4 Treatment-Emergent Adverse Events (TEAE) in combination in contrast to that of pegfilgrastim alone. Furthermore, the NDA submission is not only based on the PROTECTIVE Phase III study, but it is also backed by five more trials that disclosed the prevention of CIN in over 1,2000 sufferers in various chemotherapy treatments and cancers.